The permanent method of contraception for women continues to cause controversy, but evidence seems lost amidst the heated debate. Personal stories dominate the discourse, and while the medical community appears divided, the media demand a response from Bayer, which hides behind a generic statement.
Since 4 th November 2002, Essure’s approval date, through 25 th October 2013, the FDA received 943 reports of adverse events related to the product. The most frequently reported adverse events were pain (606), hemorrhage (140), migration of the device or device component (116), patient device incompatibility (113),and device breakage (37), among others 1 . Only three of those adverse events binge eating were featured in the information booklet that accompanied the procedure, and, according to the women we spoke with, doctors binge eating who performed the procedure weren’t informed about possible side effects either.
“I was absolutely not well-informed about the risk-benefit profile before undergoing the procedure,” said Angie Firmalino, who founded the Facebook binge eating group called Essure Problems in 2011, two years after undergoing the procedure. The group now has 7,635 members, and adds 25-50 new members each week. “I received a pamphlet that looked like a vacation brochure. Perforations, migrations, binge eating and other side effects were not listed in it,” she said, adding that her OBGYN also failed to provide adequate information concerning possible side effects.
The pamphlet has since been updated. It now features possible side effects as well as a disclaimer that it is “not intended to be comprehensive as all women have individual needs and concerns.” Among the listed adverse reactions are unsatisfactory placement of the inserts in 8% of women in clinical trials (during a three month follow-up, incorrect placement was identified in an additional 4.5% of women). “Unsatisfactory placement” includes perforations that result from the device, and migrations of the coils. Other problems listed in the new booklet include breakage, nausea, sweating, pain, cramping, vaginal bleeding, heavy periods, and ectopic pregnancy, among others.
There binge eating are three potential reasons the list of side effects was incomplete in the original binge eating booklet. One, Bayer hid trial results from the FDA. Two, the side effects are the result of long-term usage of the device, so they were not present in clinical trials, which are not designed to check long-term safety of a device. Or three, the trials conducted by the manufacturers were less than perfect. Firmalino believes the last possibility, calling Bayer’s trials “faulty and biased,” but she’s unwilling to speak about the details.
“Many women, including myself, have retained a law firm preparing to file suit against Bayer. The administrators of the Essure Problems page and I have been working closely binge eating behind the scenes with the firm, and we have collected much evidence and proof. It will all come out when the legal trials begin,” she said.
Despite a warning about possible ectopic pregnancies, according to the new information pamphlet, binge eating Essure is 99.83% effective although another form of contraception should be used for the first three months following implantation. According binge eating to Firmalino, the assurance that a woman would never again have to worry about pregnancy is very misleading.
“In our group, we have seen numerous pregnancies, some resulting in a miscarriage (on average, 55% of women pregnant with Essure will miscarry). We have seen some full term live births, some pre-term, and a handful of stillbirths. Bayer’s pregnancy rates are far from accurate,” Firmalino said.
Indeed, a new study coming out of Yale University seems to be supporting Firmalino’s observations. According to their estimate, 9.6% of women could become pregnant within 10 years of undergoing hysteroscopic sterilization, or Essure. This is nearly four times the estimated risk after a laparoscopic tubal ligation, the more traditional method.
The study, published in the journal binge eating Contraception, is the first to compare the effectiveness of the two main choices offered to women who seek a permanent binge eating form of birth control. binge eating According to the Chicago Tribune, about 345,000 American women undergo sterilization procedures each year, with Essure an increasingly popular choice because it does not require a surgical incision.
The safety of the procedure has divided the medical community. Although some doctors extended their support to Essure Problems Facebook page, admitting that there is a problem with the device, others have no doubt the procedure is the right choice for women. For example, Steve Parsons, an OBGYN and the main provider binge eating of the Essure procedure binge eating in the Netherlands, makes a bold statement that he "believes binge eating in Essure because he believes in women". He compares Essure to othe
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